Fresh Corneal Lenticule Implantation in Macular Corneal Distrophy With Relex Smile Surgery

Not Applicable

• Conditions: Macular Corneal Dystrophy
• Interventions: Procedure: Fresh Corneal Lenticule Implantation using Relex-Smile Surgery

• Registration Number: NCT04642729
• Lead Sponsor: Eye Hospital Pristina Kosovo

Brief Summary

The aim of the study is to examine the effect of fresh corneal lenticule implantation as allogenic graft taken from myopic patients to implanted in patients with macular corneal dystrophy using Visumax Femtosecond Laser Smile module surgery.

Detailed Description

Macular Corneal Dystrophy is a severe form of stromal corneal dystrophy characterized by bilateral cloudy regions within hazy stroma and eventually severe visual impairment.

Most cases of MCD are caused by mutations in the CHST6 gene encoding a protein involved in the production of keratan sulfate, which plays a role in the maintenance of corneal transparency.

According to biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding) at corneal dystrophies. Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-06-01
• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-11-21
• Study First Posted: 2020-11-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• indications for penetrating keratoplasty
• low transparec of corneae
• low visual acuity

Exclusion Criteria

• active anterior segment pathology
• previous corneal or anterior segment surgery
• any infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fresh corneal lenticule implantation	Fresh Corneal Lenticule Implantation using Relex-Smile Surgery	Using VisuMax Femtosecond Laser we make intrastromal pocket incision 2-3 mm in periphery of cornea (Because the macular dystrophy is in the center more progressive) and 150 µm deep to put fresh corneal lenticule. After one month using VisuMax we create a flap using autologous serum with purpose to remove more dead keratocytes and adding live keratocytes with aim to regenerate the metabolism of cornea.
ReLex Smile surgery	Fresh Corneal Lenticule Implantation using Relex-Smile Surgery	The myopic lenticule after Relex Smile surgery is put into BBS solution for 10 min. Under topical anesthesia, Using VisuMax Femtosecond Laser.

Primary Outcome Measures

Name	Time	Method
Increase of corneal transparency	12 months	Implanting fresh corneal lenticule we add more live stem cells and keratocytes to stabilize biomechanical stability of cornea. Also making flap and putting autologous serum after one month of implanting fresh corneal lenticule we removed more dead keratocytes from macula dystrophia and added more live keratocytes which contributed to the regeneration of the cornea.

Secondary Outcome Measures

Name	Time	Method
Increase of visual acuity	12 months	After implanting fresh corneal lenticule according to clarity of cornea visual acuity increased for 2-3 m and also softening symptoms of corneal dystrophy ex. dry eyes, sensitivity to light, pain in the eye, corneal erosion etc.

Trial Locations

Locations (1)

Eye Hospital Pristina; Pristina, Kosovo